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New Study Suggests Sleeping Pills May Raise Risk of Death
Several high-profile newspapers and news agencies have recently reported on a new study that suggests that sleeping pills are linked to an increased risk of death. Published in the British Medical Journal (BMJ), this study examined eight different types of sleeping pills separately: zolpidem (Ambien), temazepam (Restoril), eszopiclone (Lunesta), zaleplon (Sonata), triazolam (Halcion), flurazepam, barbiturates and antihistamines. Each of these sleeping medicines was associated with an increased risk of death. For those patients prescribed high doses, cancer incidence also increased. Although a positive association was found, this study alone cannot tell us that the medicines themselves are the direct cause of higher rates of death and cancer. This is because the increased risk could be due to other factors outside of the medicines, such as lifestyle issues, alcohol use, or smoking. This study does raise important questions that require further research to answer. For more information, please visit: http://bmjopen.bmj.com/content/2/1/e000850.full
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FDA Requires Lower Starting Dose of Lunesta (eszopiclone) to Reduce Risk of Next-Day Impairment
The U.S. Food and Drug Administration (FDA) is warning that Lunesta (eszopiclone), a medicine used to help with sleeping, can cause next-day impairment of driving and other activities that require alertness. As a result, the FDA has required the manufacturer of Lunesta and generic eszopiclone products to update the prescribing information (also known as the drug label) and the patient Medication Guide to include a lower recommended starting dose. The recommended starting dose of Lunesta has been decreased from 2 milligrams (mg) to 1 mg at bedtime for both men and women. The 1 mg dose can be increased to 2 mg or 3 mg if needed, but the higher doses are more likely to result in next-day impairment of driving and other activities that require full alertness. Using a lower dose means less eszopiclone will remain in the body in the morning hours. The dose change is based on a recent study that showed, compared with an inactive pill (placebo), Lunesta 3 mg was associated with severe next-morning impairment of driving skills, memory, and coordination in both men and women 7.5 hours after taking the medicine. The study found that the 3 mg dose can cause impairment as long as 11 hours after the medicine is taken. Patients were often unaware they were impaired. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm397260.htm
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Date Published Title Drug Source
2012-02-29 New Study Suggests Sleeping Pills May Raise Risk of Death Eszopiclone MediGuard CRT
2014-05-19 FDA Requires Lower Starting Dose of Lunesta (eszopiclone) to Reduce Risk of Next-Day Impairment Eszopiclone FDA
2008-05-01 New black box warning Etanercept Manufacturer
2008-06-04 Early communication regarding cancer link in children Etanercept FDA
2008-09-04 TNF Blockers Increase the Risk of Fungal Infections Etanercept FDA
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Etanercept FDA
2010-01-28 Recall of Several Lots of Enbrel (etanercept) SureClick Autoinjector, 50 mg/mL Etanercept FDA
2011-04-15 FDA Continues to Receive Reports of Rare Cancer in Patients Treated With TNF Blockers, Azathioprine, and/or Mercaptopurine Etanercept FDA
2011-09-07 FDA Updates Labels for Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab) Etanercept FDA
2011-11-04 FDA Requires Closer Review of Adverse Event Reports for Tumor Necrosis Factor (TNF) Blockers Etanercept FDA
2012-02-01 Pfizer Announces Voluntary Nationwide Recall Of Lo/Ovral-28 And Norgestrel/Ethinyl Estradiol Tablets Due To Tablet Mix-Up Ethinyl Estradiol with Norgestrel Manufacturer
2012-02-27 Glenmark Generics Recalls Birth Control Pills Due To Packaging Error that May Increase Risk of Unintended Pregnancies Ethinylestradiol with Norgestimate FDA
2013-07-08 Sandoz Announces Voluntary Recall of One Lot of Estarylla Ethinylestradiol with Norgestimate FDA
2008-12-17 New FDA Warning on Seizure Medications Ethosuximide FDA
2008-12-17 New FDA Warning on Seizure Medications FDA
2007-10-01 Early communication of ongoing safety review Etidronic Acid FDA
2008-01-07 FDA Communication Regarding Musculoskeletal Pain Etidronic Acid FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Etidronic Acid FDA
2009-08-28 Warning About Serious Skin Reactions with Use of Intelence Etravirine Manufacturer
2009-08-28 Rivistigmine (Exelon) Linked to Increased Risk of Fainting and Low Heart Rate Exelon MediGuard CRT
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